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NDC 41250-0360-57 Meijer SPF 8 .9; 2; 1.5 g/100g; g/100g; g/100g Details

Meijer SPF 8 .9; 2; 1.5 g/100g; g/100g; g/100g

Meijer SPF 8 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. The primary component is AVOBENZONE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	41250-0360
Product ID	41250-360_25f5a29f-8969-4a9e-b6c3-205ac6462049
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Meijer SPF 8
Proprietary Name Suffix	n/a
Non-Proprietary Name	AVOBENZONE, OCTOCRYLENE, OXYBENZONE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	.9; 2; 1.5
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	AVOBENZONE; OCTOCRYLENE; OXYBENZONE
Labeler Name	Meijer Distribution Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41250-0360-57 (41250036057)

Pricing Information	N/A
NDC Package Code	41250-360-57
Billing NDC	41250036057
Package	295 g in 1 BOTTLE (41250-360-57)
Marketing Start Date	2016-05-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cb9d12eb-6645-43f4-9f81-31af13c5c68d Details

Active Ingredients

AVOBENZONE 0.9%, OCTOCRYLENE 2.0%, OXYBENZONE 1.5%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

May stain some fabrics.

Directions

apply liberally 15 minutes before sun exposure
reapply
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
children under 6 months of age: Ask a doctor

Inactive ingredients

Water, Diisopropyl Adipate, Mineral Oil, Propylene Glycol, Petrolatum, Polyglyceryl-3 Methylglucose Distearate, Caprylyl Glycol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, VP/Eicosene Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea), Butter, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Disodium EDTA, Camellia Sinensis Leaf Extract, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder, Panthenol, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract, Phenoxyethanol, Methylparaben, Benzyl Alcohol, Propylparaben, Fragrance.

Other information

protect this product from excessive heat and direct sun

Principal Display Panel

NDC 41250-360-57

meijer

Sunscreen lotion

hypoallergenic

moisturizing

SPF 8

Water Resistant

(80 minutes)

10 Fl. Oz. (295 mL)

INGREDIENTS AND APPEARANCE

MEIJER SPF 8

avobenzone, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-360
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.9 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PETROLATUM (UNII: 4T6H12BN9U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
TROLAMINE (UNII: 9O3K93S3TK)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BANANA (UNII: 4AJZ4765R9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-360-57	295 g in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/16/2016

Labeler - Meijer Distribution Inc (006959555)

Revised: 5/2016

Document Id: 25f5a29f-8969-4a9e-b6c3-205ac6462049

Set id: cb9d12eb-6645-43f4-9f81-31af13c5c68d

Version: 1

Effective Time: 20160519